Respiratory Today—March 13, 2026

This week’s Respiratory, Research update highlights regulatory progress, late-stage clinical data, new Phase 3 plans, RNA-editing investment, and conference data presentations across multiple pulmonary diseases.

In Today’s Newsletter

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🫁 Meiji starts Japan Phase 3 for REZUROCK in CLAD [1] [Japan • 05 Mar 2026]

https://www.meiji.com/global/news/2026/pdf/260305_02.pdf
Context: REZUROCK (belumosudil, Meiji Seika Pharma / Romeck Pharma; selective ROCK2 inhibitor) is already marketed in Japan for chronic graft-versus-host disease.
Key point: Meiji Seika Pharma said Phase 3 in Japan has started for chronic lung allograft dysfunction (CLAD), within Sanofi’s global randomized, placebo-controlled, double-blind study.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Wave secures late-breaking ATS slot for WVE-006 in AATD [2] [US • 05 Mar 2026]

https://ir.wavelifesciences.com/news-releases/news-release-details/wave-life-sciences-announces-acceptance-late-breaking-oral
Context: WVE-006 (Wave Life Sciences; GalNAc-conjugated RNA-editing oligonucleotide) is being studied in RestorAATion-2 for alpha-1 antitrypsin deficiency.
Key point: Wave said ATS accepted a late-breaking oral that will include new data from the 400 mg multidose cohort and 600 mg single-dose cohort.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫁 Savara advances MOLBREEVI across US, EU, and UK review steps [3] [US • 06 Mar 2026]

https://investors.savarapharma.com/news/news-details/2026/Savara-Provides-Regulatory-Update-on-the-MOLBREEVI-Development-Program-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx
Context: MOLBREEVI (Savara; molgramostim inhalation solution) is under review for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
Key point: Savara said the FDA Day 74 letter indicated no Advisory Committee is planned, the PDUFA date remains 22 Aug 2026, and the EMA filing has been submitted.
Implication: Introduces competition that may affect pricing and formulary access.

🗣️ Trevi gets FDA alignment for Phase 3 in IPF-related chronic cough [4] [US • 09 Mar 2026]

https://ir.trevitherapeutics.com/news-releases/news-release-details/trevi-therapeutics-announces-completion-end-phase-2-meeting-0
Context: Haduvio (Trevi Therapeutics; oral nalbuphine ER) is being developed for chronic cough in idiopathic pulmonary fibrosis.
Key point: Trevi said its end-of-Phase 2 FDA meeting aligned the remaining development plan, including two randomized, placebo-controlled Phase 3 trials.
Implication: May influence prescriber choice and payer reviews pending full data.

💰 Korro raises $85 million to fund RNA-editing milestones [5] [US • 09 Mar 2026]

https://ir.korrobio.com/news-releases/news-release-details/korro-announces-oversubscribed-85-million-private-placement
Context: Korro Bio develops RNA-editing medicines and said the PIPE was led by Venrock Healthcare Capital Partners with new and existing investors.
Key point: Korro announced an oversubscribed $85 million private placement, with proceeds expected to support clinical data milestones for KRRO-121 and its GalNAc-conjugated AATD program.
Implication: Signals pipeline investment and modality expansion.

📘 United Therapeutics publishes full TETON-2 Phase 3 results for Tyvaso in IPF [6] [US • 11 Mar 2026]

https://ir.unither.com/press-releases/2026/03-11-2026-221408955
Context: TETON-2 was a 597-patient, randomized, double-blind, placebo-controlled Phase 3 study of nebulized Tyvaso (treprostinil) in idiopathic pulmonary fibrosis over 52 weeks.
Key point: United Therapeutics said NEJM published full results showing statistically significant preservation of FVC and fewer clinical worsening events versus placebo.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

• Respiratory drug development remains active across transplant complications, fibrotic lung disease, chronic cough, autoimmune PAP, and alpha-1 antitrypsin deficiency.
• Regulatory momentum is visible, with Savara moving through FDA and EMA review steps and Trevi defining a Phase 3 path with FDA.
• RNA editing continues to draw attention in pulmonary-linked rare disease, with updates from Wave and financing support for Korro.
• IPF remains a crowded but evolving field, with United Therapeutics publishing pivotal Tyvaso data and Trevi advancing a cough-focused program.

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FAQ

What changed for REZUROCK in chronic lung allograft dysfunction?

Meiji Seika Pharma said Phase 3 in Japan has started for REZUROCK (belumosudil) in CLAD, as part of a global Phase 3 study run by Sanofi. The source frames this as a Japan development start, not a data readout. [1]

What will Wave present at ATS for WVE-006?

Wave said its late-breaking oral will include RestorAATion-2 data for WVE-006 from the 400 mg multidose cohort and the 600 mg single-dose cohort in AATD. The company also said it is advancing regulatory engagement on a possible accelerated approval path. [2]

Where does Savara stand with MOLBREEVI in autoimmune PAP?

Savara said the FDA Day 74 letter indicated no Advisory Committee is planned and listed a PDUFA target action date of 22 Aug 2026. The company also said it submitted to EMA and remains on track for a UK MHRA filing by end-Q1 2026. [3]

What did FDA alignment mean for Trevi’s Haduvio program?

Trevi said the end-of-Phase 2 meeting aligned the remaining development program for nalbuphine ER in IPF-related chronic cough. The company plans two Phase 3 trials and additional Phase 1 work to support a future NDA. [4]

Why does Korro’s financing matter for pulmonary-adjacent RNA editing?

Korro said the $85 million PIPE is intended to support multiple value inflection points, including clinical data for KRRO-121 and its AATD program. The company also said the financing should extend cash runway into the second half of 2028. [5]

What did TETON-2 show for Tyvaso in IPF?

United Therapeutics said TETON-2 met its primary endpoint on absolute FVC at week 52 and showed fewer clinical worsening events versus placebo. The company also said 75.4% of patients were on background antifibrotic therapy, which supports relevance to real-world treatment settings. [6]

Entities / Keywords

REZUROCK, belumosudil, Meiji Seika Pharma, Romeck Pharma, Sanofi, ROCK2 inhibitor, chronic lung allograft dysfunction, CLAD
WVE-006, Wave Life Sciences, RestorAATion-2, RNA editing, GalNAc-conjugated oligonucleotide, alpha-1 antitrypsin deficiency, AATD
MOLBREEVI, molgramostim inhalation solution, Savara, autoimmune pulmonary alveolar proteinosis, autoimmune PAP, FDA Day 74 letter, PDUFA, EMA, MHRA
Haduvio, nalbuphine ER, Trevi Therapeutics, idiopathic pulmonary fibrosis, IPF-related chronic cough
Korro Bio, KRRO-121, OPERA, RNA editing, PIPE financing, hyperammonemia, urea cycle disorders
Tyvaso, treprostinil, United Therapeutics, TETON-2, NEJM, FVC, idiopathic pulmonary fibrosis, IPF

References